PSD Exam 2

What is an Adverse Drug Event (ADE)?

An incident that results in half to a patient

What is preventable adverse drug event?

Medication error, due to humans

What is an unpreventable adverse drug event?

ADR or SE, due for drugs

What is a medication error?

Mistakes in the medication use process that may result in negative outcomes

What may medication errors result in

• An adverse drug event if a patient is harmed

• A near miss if a patient is nearly harmed

  • no harm

T/F Medication errors are always preventable

True

When can medication errors occur?

At any step in medication use process

What is Pharmacovigilance?

science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem

What dose the Swiss cheese model of error mean?

If hards line up in the multistep system then it could lead to harm based off of weaknesses in the system (gaps)

Example of the Swiss cheese model in the Eric cropp case.

• Computer system down

• Pharmacy tech was distracted

• A backlog of physician orders had developed

• Nurse requesting medication immediately

• Short staffed

What national organization are put in place to improve patient safety and raise awareness?

• Institute of medicine (IOM)

• Institute for healthcare improvement (IHI)

• National quality forum (NQF)

• The leapfrog group

• The joint commission

• Agency for healthcare research (AHRQ)

• Institute of safe medication practices (ISMP)

What is the joint commission charged with in hospitals?

Meeting quality standards and patient standards

How often are national patient safety goals prepared and by who?

Annually by joint commission

What are national patient safety goals designed to do?

Stimulate health care organizations improvement for several of the most challenging patient safety issues

• Specific goals for ambulatory, behavioral, home care, and hospitals

What are some of the 2022 hospital national patient safety goals?

• Identify patients correctly

• Improve staff communication

• Use medicines safely

• Use alarms safely

• Prevent infection

• Identify patient safety risk

  • Prevent mistakes in surgery

What is the difference between the 2022 and 2023 safety goals?

Improve health care equity

• Improving health care equity is a quality and patient safety priority. For example, health care disparities in the patient population are identified and a written plan describes ways to improve health care equity

What does IOM state medical errors are often due to?

Problems in embedded in inadequately designed healthcare systems rather than as a result of negligent healthcare practitioners

What is an example of human error?

Pharmacist verifies an incorrect dose for a patient based on renal function

What is the definition, how to manage, and action for behavior?

Definition: A slip, lapse, or mistake

How to manage: Process improvement, design, training

Action for behavior: Console

What is an example of at-risk behavior?

Overriding computer alerts without consideration

What is the definition, how to manage, and action for at-risk behavior?

• Definition: A choice; risk was believed to be justified or insignificant

• How to manage: Increase situational awareness, create incentives for healthy behavior

  • Coach

What is the example of reckless behavior?

• Working while intoxicated

What is the definition, how to manage, and action for reckless behavior?

• Definition: Disregard of substantial and unjustified risk

• How to manage: Remedial action; punitive action

  • Punish

What is just culture?

• Many errors go unreported by health care workers

• •Only serious or harmful medication errors are reported; errors that do not cause harm but necessitate a systems fix to prevent them in the future are not reported

  

Why are health care workers are afraid to report?

Fear of retribution including the loss of professional licensure and even imprisonment

What is the ideal safety system?

• Robust easy reporting process

• Does not assign blame

• Transparent discussion is rewarded

  • Continuous cycle of problem identification and process improvement

What are ways we can prevent medication error?

•Culture of safety

•Continuous evaluation of medication use system

•Involve the patient – education

•Health care providers need adequate access to pt. info

•Technology

•Adequate knowledge base – continuing education

•Medication reconciliation at transfer of care

•Surveillance systems

•Monitoring, reporting, evaluating, and communicating

•DUEs/MUEs

•Protocol development

What are two factors that influence the identification of an ADR/ADE being associated with a drug?

• Frequency of occurrence in general population

  • Timing

What is frequency of occurrence based on?

a.              Is the “reaction/event” something that rarely happens in the general population?  

b.              Is the “reaction/event” something that more frequently occurs in the general population?    Is there already a “high background frequency”?

How does timing play a factor in ADR/ADE associated with a drug?

How long after taking a drug did the reaction occur?

a.              Those that occur shortly after using a drug                                       

b.              Those that occur with long term use of the drug                              

c.              Those that occur long after drug has been discontinued                   

What does FDA drug approval recognize?

The possibility of future rate serious or common delayed ADRsW

What are the strengths of Pre-market?

• Clinically confirmed ADE, well described

• Known denominator

• Clean report

  • Can be followed up long term

What are the limitations of pre-marketing surveillance?

• <10,000 pts

• Pts without multiple disease states (not as realistic)

• Too simple/narrow indication

  • Not long term

When does post-marketing surveillance occur?

Occurs after the drug is on the market

What are the benefits of post-marketing surveillance?

• Long term therapy

• >10,000 pts- true incidence

• Presence of multiple disease states and drugs (diverse patient populations, drug interactions)

  • Low frequency reactions detected and better estimate of incidence of all reactions

What are the limitations of Post marketing surveillance?

• Low reporting rate

• Less detailed reports

  • Uncertain casual relationship (disease states, drugs)

What are the types of post-marketing surveillance?

a.              Phase IV trials – FDA may require continued trials be done once drug is marketed

 

b.              Clinical trials with the drug      

 

c.              Drug registries – monitors outcomes when a drug is used in pregnancy

 

d.         International data on adverse drug reactions

 

e.          FDA sponsored research specifically aimed to define reaction

 

f.          Case Reports

T/F Phase IV trials may require continued trials to be done once a drug is marketed

True

What do drug registries monitor?

Outcomes when a drug is used in pregnancy

What are case reports?

A brief description of an event notices with a possible relationship to a drug

What does the clin-alert do?

Summarizes case reports of ADRs, drug interactions and market withdrawals

What are first reports?

Notice the first documented report of an ADE

What does reactions weekly do?

• Summarizes case reports of adverse drug reactions

• Summarizes adverse drug reaction news reports such as:

  • Labeling changes

  • Drug Withdrawals

  • ADR research

    • Current topics

What is the most spontaneous reporting system?

The most efficient way to detect rate adverse events that occur with drug use

Mandated the FDA develop a system in 1962

What are the goals of MedWatch?

• To promote and facilitate the reporting of ADEs and problems to the FDA

  • To communicate safety information to the medical community and the public

Medwatch requires mandatory reporting by manufacturers of:

• Medications

• Devices

• Cosmetics

• Dietary Supplements

  • Biologics

Who is able to voluntary report to Medwatch?

Consumers

Health care professionals

What should be reported to medwatch?

• Unexpected side effects or ADE’s

• Product Quality problem

• Product use/medication errors

  • Therapeutic failures

What are unexpected side effects or ADEs that should be reported to medwatch?

•       Death – 

 

•       Life-threatening

 

•       Hospitalization (initial or prolonged)

 

•       Disability or Permanent damage        

 

•       Congenital anomaly / Birth Defect

 

•       Required medical or surgical intervention to prevent permanent impairment or damage

 

•       Other serious (important medical events)   

 

•       New and Unexpected reactions – especially from NEW drugs

 

•       Unusual increase in frequency or severity of reaction

What are examples of product quality problem?

• Suspected counterfeit product                  

• Contamination                                          

• Questionable stability

• Defective components                               

• Poor packaging or product mix-up           

• Labeling concerns  

How can you report to medwatch?

• Report by phone

• Fax

• Mail

  • On-line MedWatch form 3500

What are the possible outcomes of reporting?

•         Name changes                    Packaging changes

•         Labeling changes         

•         Black-Box warnings     

•         Product recalls

•         Inspection of manufacturer facilities

•         Publication in MedWatch Case studies

•         FDA postings

•         “Dear Health Care Professional” letters         

Drug withdrawn from market           

What should not be reported to MEdwatch?

Veterinary products

tobacco products

vaccines (uses a separate program)

What program are vaccines reported to?

VAERS (Vaccine adverse event reporting system)

What are JCAHO requirements?

•       Definition of an ADE

•       Concurrent method of monitoring and reporting

•       System to evaluate causality

•       System to use results of monitoring to improve safety – Quality Improvement

What are prospective methods of detection of ADR/ADEs?

Look ahead for ways to prevent ADRs/ADEs before they occur

What are concurrent systems for detection of ADR?

looking for ADRs/ADEs as they happen

 

                                               i.     Patient Chart / EHR review                          

 

                                             ii.     Spontaneous / Voluntary reporting of events        

 

                                            iii.     Surveillance systems – Rx /Lab databases to look for “Indicator Drugs”

 

                                    Examples:

                                    Atropine – for bradycardia

                                    Dextrose 50% - for hypoglycemia

                                    Diphenhydramine - antihistamine, allergic reactions

                                    Epinephrine – for anaphylaxis 

                                    Flumazenil  – benzodiazepine antagonist

                                    Naloxone  – opioid antagonist

                                    Protamine – antidote for heparin

                                    Sodium polystyrene sulfonate for hyperkalemia

                                    Vitamin K – antidote of warfarin

What are retrospective systems of detection of ADRs?

chart review, coding in medical record – eg ADR/ADE’s in past year

What is incompatibility?

- a phenomenon which occurs when one drug product is mixed with another to produce, by physicochemical means, a product unsuitable for administration because of modification of the drug or because of some physical change.

What is instability?

a phenomenon which occurs when a LVP vehicle or product is modified due to storage conditions (eg time light,  temperature, sorption). The product is unsuitable for administration.  Instability is said to have occurred when the LVP  vehicle or product loses more than 10% of to  labeled potency from the time of preparation to the time of complete administration.

What are physical incompatibilities?

Precipitations

• Insoluble salts

• Cosolvent formulations

• pH dependent solubility

Sorption phenomena

Complexation

salting out

What is an example of insoluble salts?

Calcium and phosphates in TPN (temp, pH, concentration, amino acids, times)

What are examples of cosolvent formulation examples?

Diazepam and phenytoin (in propylene glycol, ethanol)

What is an example of pH dependent solubility?

Phenobarbital

What is an example of sorption phenomena?

nitroglycerin, insulin , diazepamW

What is an example of complexation?

insoluble chelates - tetracycline and Ca

What is an example of salting out?

decreased solubility of non-electrolytes in presence of strong electrolytes, eg. diazepam

What are chemical incompatibilities?

• Reduction/Oxidation

  • sympathomimetic amines

• Photodegradation

  • need to shield from light

                            eg nitroprusside, amphotericin B

• Hydrolysis

  • Major cause of instability of drugs in solution

What factors influence chemical degradation?

 

    1. pH - greater degradation at extremes

 

 

    2. Temperature increased temperature increases degradation

What are questions that may be asked about compatibility?

   1. Can        be mixed with          in a syringe?

   2. Is          compatible with         in an IV?

   3. Is           stable in             ?

   4. How long is             stable after reconstitution?

   5. Can         be piggybacked into a line with          ?

   6. How can a liquid/rectal/topical preparation of         be prepared?

What is necessary background information?

1. Drug dose or concentration

     2. IV Fluid – all IV fluids currently running?

     3. Intended use of product – could an alternate drug be used?

     4. Dosing Schedule or rate of infusion -should an alternate schedule be used?

     5. Number and types of IV lines – central vs peripheral, etc.

     6. Potential for additional lines

     7. Alternate routes of administration

     8. Type of container

What is a pharmacists professional responsibility?

Ensure Stability, compatibility and safety/efficacy

What does the package insert/Daily med tell us about iv compatibility?

Stability

            Diluents

            Storage requirements

           

C - 1 or more – of the following: Physically compatible - no visible sign

                                                                          Stability of at least 24 hours ( >90% )

                                                                          Stability for the entire test period - sometimes < 24 hours)

INC- Physical incompatibility is defined as?

 > 10 % decomposition of one or more components in 24 hours or less 

What does kings guide to parenteral admixtures tell us?

Stability and compatibilitiy

Trissels 2.0 is the same as trusses handbook

FALSE

What does Drugdex tell us?

Variable, stability, compatibility, some extemporaneous compounding

How can we manage unavoidable incompatibilities?

A.  Can the constant infusion line be safely turned off to permit infusion of the incompatible drugs?

      B. Flush the line completely before and after incompatible drug.

      C. Another IV Line or Y site?

      D. Alternate route of administration? IM, oral, topical  

      E. How important is this combination of drugs in maintaining this patient’s status?

 

WWhat sources should be used for other drugs in solutions or piggybacks?

Trissels Handbook,ASHP Injectable Drugs, or Online

Guide To Parenteral AdmixturesA

What are secondary (not major sources for questions related to other drugs or piggybacks)

 Micromedex

 Product Information / Insert

 Facts and Comparisons /Lexi Drug Info Handbook

 AHFS DI

What should we use for compatibilities with drugs in syringes

ASHP Injectable Drug Information / Trissels Handbook of Injectable Drugs

Trissels 2.0 – in Lexi, MDX

Where should we get information about non-commercially available dosage forms

              Remington’s

              Extemporaneous Dosage Forms (available from ASHP)

              Pediatric Drug Formulations

              Drugdex

              Martindale’s – Complete Drug Reference

              Micromedex

              Lexi Drug Information Handbook

            AHFS DI

What is the goal of health information technology for economic and clinical health act?

• Promote and expand the adoption of EHR

What did the HITECH act encourage?

healthcare providers to adopt electronic health records and improve privacy and security protections for healthcare data.

How was this HITECH Act achieved?

financial incentives for adopting EHRs and increased penalties for violations of the HIPAA Privacy and Security Rules

How does the ASHP define IT Pharmacy?

The use and integration of data, information, knowledge and technology and automation in the medication-use process for the purpose of improving health outcomes.”

What are informatics Pharmacist also known as?

• Informaticist

• Analyst

• Informatics specialist

  • Clinical IT pharmacist

What do they do?

uconfigure and maintain pharmacy systems and technology involved in the Medication Use Process

Where are Informatics pharmacists found

uPrimarily in the hospital setting but also present in other pharmacy practices (managed care, industry, regulatory, etc.)

What is the pharmacy operations of IT pharmacist?

•Maintaining pharmacy systems

•Purchasing and Billing

•NDC and barcode scanning

WWhat are break-fixes?

•Helpdesk tickets from end-users

•

•Unexpected system breaks

What enhancements do IT pharmacists do?

•New upgrades or implementations

•

•Building clinical alerts, order sets, or initiatives

What data analytics do IT pharmacists do?

•Medication use evaluations

•Medication safety reports

•Research projects

What are the elements of the medication use process?

uProvider Ordering

uPharmacist Verification, Processing, and Dispensing

uMedication Administration

uPurchasing and Inventory

uBilling and Finance

Monitoring and Reporting

T/F Pharmacy informatics play a role in each step of medication use process

True

What does a good EHR have?

applications that can communicate and share data with each other as well as other outside entities

What does the Computerized provider order entry do?

•Build and configure standard orders for providers

• •Medications, doses, routes, frequencies, durations, priorities

  •Order sets

  •Clinical decision support (Alerts)

  •Hospital Policies/P&T Committee

  •Formulary vs. Non-Formulary vs. Restricted

What is allowed in Pharmacist verification, processing and dispensing?

uEHR Pharmacy application allows you to receive, verify, and allow for dispensing of the medication

uApplications for TPN, compounded IVs, Chemotherapy preparation & checking

uApplications for checking first dose, cart fill, cabinet restock

What does the MAR ensure?

Right drug, right patient, right dose, right route, right time